New Animal Drugs for Use in Animal Feeds; Tiamulin, 22667-22668 [2012-9196]

Download as PDF Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Rules and Regulations By order of the Board of Governors of the Federal Reserve System, April 12, 2012. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 2012–9211 Filed 4–16–12; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA–2012–0226; Airspace Docket No. 12–ASO–10] RIN 2120–AA66 Amendment of Restricted Area R– 2917, De Funiak Springs, FL Federal Aviation Administration (FAA), DOT. ACTION: Final rule. AGENCY: This action modifies restricted area R–2917 by reducing the lateral and vertical dimensions of the area. The U.S. Air Force has determined that a smaller restricted area is needed to ensure that aircraft carrying certain electro-explosive devices remain a safe distance from an FPS–85 radar site. DATES: Effective date 0901 UTC, May 31, 2012. FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace, Regulations and ATC Procedures Group, AJV–11, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267–8783. SUPPLEMENTARY INFORMATION: wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: Background On January 2, 1996, the FAA published a final rule in the Federal Register to expand the lateral and vertical dimensions of restricted area R– 2917, De Funiak Springs, FL, which surrounds an FPS–85 radar system located at that site (61 FR 0004). The expanded restricted area consisted of a 2.5 nautical mile radius, from the surface up to, but not including, Flight Level (FL) 230. The purpose of R–2917 is to provide protected airspace around the radar site because the radio frequency (RF) energy emitted by the radar has the potential to activate electro-explosive devices (EED) carried on board certain aircraft. It should be noted that R–2917 is located within the confines of a much larger restricted area, R–2914A, which extends from the surface to unlimited altitude. A recent revision to Air Force explosive safety standards guidance revised the formula for computing the VerDate Mar<15>2010 14:20 Apr 16, 2012 Jkt 226001 hazards to EED from FPS–85 RF radiation. As a result, a smaller safe separation distance is required for aircraft carrying EED. This allows the size of R–2917 to be reduced to a onenautical mile radius up to 5,000 feet MSL. The smaller restricted area R–2917 remains totally contained within existing restricted area R–2914A. 22667 Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows: PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: ■ The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 to change the lateral and vertical dimensions of R–2917, De Funiak Springs, FL, from the current 2.5nautical mile radius circle, extending from the surface to, but not including FL 230, to a one-nautical mile radius circle, extending from the surface to 5,000 feet MSL. Because this amendment reduces the size of restricted airspace within the confines of a larger existing restricted area and does not increase the burden on the public, notice and public procedures under 5 U.S.C. 553(b) are unnecessary. The FAA has determined that this action only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311c., FAA Order 1050.1E, Environmental Impacts: Policies and Procedures. This action reduces the vertical and lateral dimensions of special use airspace; therefore, it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment. HHS. List of Subjects in 14 CFR Part 73 Airspace, Prohibited areas, Restricted areas. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 § 73.29 [Amended] 2. § 73.29 is amended as follows: * * * * * ■ 1. R–2917 De Funiak Springs, FL [Amended] By removing the current Boundaries and Designated altitudes and substituting the following: Boundaries. A circle with a 1-nautical mile radius centered at lat. 30°34′21″N., long. 86°12′53″W. Designated altitudes. Surface to 5,000 feet MSL. Issued in Washington, DC on April 12, 2012. Ellen Crum, Acting Manager, Airspace, Regulations and ATC Procedures Group. [FR Doc. 2012–9186 Filed 4–16–12; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA–2012–N–0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: ACTION: Food and Drug Administration, Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to the production indications for use of increased rate of weight gain and improved feed efficiency in swine. DATES: This rule is effective April 17, 2012. SUMMARY: FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish E:\FR\FM\17APR1.SGM 17APR1 22668 Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Rules and Regulations Pl., Rockville, MD 20855, 240–276– 8341, email: cindy.burnsteel@fda.hhs.gov. Novartis Animal Health U.S., Inc. (Novartis), 3200 Northline Ave., suite 300, Greensboro, NC 27408, has requested that FDA withdraw approval of those parts of NADA 139–472 for DENAGARD (tiamulin) Type A medicated article pertaining to the production indications for use of increased rate of weight gain and improved feed efficiency in swine. Novartis requested voluntary withdrawal of approval of these indications for use because the product is no longer marketed for these uses. Revised product labeling reflecting the withdrawal of these indications has been approved in a supplement to NADA 139–472. Elsewhere in this issue of the Federal Register, FDA gave notice that the approval of those parts of NADA 139– 472 pertaining to the production indications for use of increased rate of SUPPLEMENTARY INFORMATION: weight gain and improved feed efficiency in swine is withdrawn, effective April 17, 2012. As provided for in the regulatory text of this document, the animal drug regulations are amended to reflect this withdrawal of approval. With the withdrawal of approval of the production indications for tiamulin, the lowest concentration of the drug in feed now has a preslaughter withdrawal period. In accordance with 21 CFR 558.3(b)(1)(ii), tiamulin is now a Category II drug, and the table in 21 CFR 558.4(d) is revised to reflect that change. However, the maximum concentration of tiamulin in Type B feeds is not being increased from the current 3.5 grams per pound (g/lb) because there is an approved 5-g/lb Type A medicated article. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director of the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. 2. In paragraph (d) of § 558.4, in the ‘‘Category I’’ table, remove the entry for ‘‘Tiamulin’’; and in the ‘‘Category II’’ table, alphabetically add a new entry for ‘‘Tiamulin’’ to read as follows: ■ § 558.4 Requirement of a medicated feed mill license. * * * (d) * * * * * CATEGORY II Drug Assay limits percent 1 Type A Type B maximum (100x) * * Tiamulin .................................................... * * 113.4 g/lb, 100–108 ................................ 5 and 10 g/lb, 90–115 ............................. Assay limits percent 1 Type B/C 2 * * 3.5 g/lb (0.8%) ......................................... * * * * * * * 90–115 70–130 * 1 Percent of labeled amount. given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed. 2 Values * * § 558.600 * * * administrative changes to other sections. DEPARTMENT OF STATE [Amended] 22 CFR Parts 120 and 123 3. In § 558.600, in the table, remove and reserve paragraph (e)(1)(i). ■ Dated: March 21, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2012–9196 Filed 4–16–12; 8:45 am] RIN 1400–AC85 Effective Date: This rule is effective May 17, 2012. [Public Notice: 7846] FOR FURTHER INFORMATION CONTACT: DATES: Amendment to the International Traffic in Arms Regulations: International Import Certificate BIS–645P/ATF–4522/ DSP–53 and Administrative Changes BILLING CODE 4160–01–P Department of State. Final rule. AGENCY: ACTION: wreier-aviles on DSK5TPTVN1PROD with RULES VerDate Mar<15>2010 14:20 Apr 16, 2012 Jkt 226001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 The Arms Export Control Act authorizes the President to control the import and export of defense articles. Executive Order 11958, as amended, delegated the authority to regulate permanent and temporary exports and temporary imports of defense articles to the Secretary of State, and delegated the authority to regulate permanent imports of defense articles to the Attorney SUPPLEMENTARY INFORMATION: The Department of State is amending the International Traffic in Arms Regulations (ITAR) to remove reference to the International Import Certificate (Form BIS–645P/ATF–4522/ DSP–53). This amendment ceases the Department’s practice of accepting DSP– 53 submissions. Instead, the DSP–61 is to be used by importers when necessary. The Department also is making SUMMARY: Ms. Candace M. J. Goforth, Acting Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663–2792, email DDTCResponseTeam@state.gov. ATTN: International Import Certificate, ITAR Section 123.4. E:\FR\FM\17APR1.SGM 17APR1

Agencies

[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Rules and Regulations]
[Pages 22667-22668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9196]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs for Use in Animal Feeds; Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal of approval of those parts 
of a new animal drug application (NADA) for a tiamulin Type A medicated 
article that pertain to the production indications for use of increased 
rate of weight gain and improved feed efficiency in swine.

DATES: This rule is effective April 17, 2012.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish

[[Page 22668]]

Pl., Rockville, MD 20855, 240-276-8341, email: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Novartis Animal Health U.S., Inc. 
(Novartis), 3200 Northline Ave., suite 300, Greensboro, NC 27408, has 
requested that FDA withdraw approval of those parts of NADA 139-472 for 
DENAGARD (tiamulin) Type A medicated article pertaining to the 
production indications for use of increased rate of weight gain and 
improved feed efficiency in swine. Novartis requested voluntary 
withdrawal of approval of these indications for use because the product 
is no longer marketed for these uses. Revised product labeling 
reflecting the withdrawal of these indications has been approved in a 
supplement to NADA 139-472.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that the approval of those parts of NADA 139-472 pertaining to the 
production indications for use of increased rate of weight gain and 
improved feed efficiency in swine is withdrawn, effective April 17, 
2012. As provided for in the regulatory text of this document, the 
animal drug regulations are amended to reflect this withdrawal of 
approval.
    With the withdrawal of approval of the production indications for 
tiamulin, the lowest concentration of the drug in feed now has a 
preslaughter withdrawal period. In accordance with 21 CFR 
558.3(b)(1)(ii), tiamulin is now a Category II drug, and the table in 
21 CFR 558.4(d) is revised to reflect that change. However, the maximum 
concentration of tiamulin in Type B feeds is not being increased from 
the current 3.5 grams per pound (g/lb) because there is an approved 5-
g/lb Type A medicated article.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director of the Center for Veterinary Medicine, 21 
CFR part 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


0
2. In paragraph (d) of Sec.  558.4, in the ``Category I'' table, remove 
the entry for ``Tiamulin''; and in the ``Category II'' table, 
alphabetically add a new entry for ``Tiamulin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                                                                   Assay limits
                  Drug                     Assay limits percent \1\     Type B maximum  (100x)      percent \1\
                                                    Type A                                         Type B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Tiamulin................................  113.4 g/lb, 100-108.......  3.5 g/lb (0.8%)...........          90-115
                                          5 and 10 g/lb, 90-115.....                                      70-130
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make Type C medicated feed.

* * * * *


Sec.  558.600  [Amended]

0
3. In Sec.  558.600, in the table, remove and reserve paragraph 
(e)(1)(i).

    Dated: March 21, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-9196 Filed 4-16-12; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.